Unique Device Identifier (UDI)
WORK GROUP TITLE:
UDI Capture Work Group
CASE STUDY PARTICIPANTS:
Wendy Watson, OR Supply Chain Manager at University Health Network
CASE STUDY ORGANIZATION:
University Health Network (UHN) serves the residents of Toronto, Ontario, Canada’s largest city, and the surrounding communities. UHN is…
WORK GROUP TITLE:
UDI Capture Work Group
CASE STUDY PARTICIPANTS:
Jim Booker, Manager of Master Data Management, Supply Chain, Stanford Health Care
CASE STUDY ORGANIZATION:
WORK GROUP TITLE:
UDI Capture Work Group
CASE STUDY PARTICIPANTS:
James Phillips, Consulting Manager, DSI, the Office of Data Standards and Interoperability, Franciscan Missionaries of Our Lady Health System (FMOLHS)
CASE STUDY ORGANIZATION:
A UDI Capture Work Group Case Study at the Beaver Dam Community Hospitals, Inc.
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By: Suzanne Alexander-Vaughn
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By: Karen Conway
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Medical device manufacturers have been working hard to comply with the new Unique Device Identification (UDI) regulations from the FDA that are aimed at bolstering the safety of medical devices. The UDI system, which the agency says will be phased in over several years, is intended to improve…
This Awareness Brief provides a quick reference to the Draft Guidance for UDI Convenience Kits, released by the FDA in January 2016. The draft guidance defines the term “convenience kit” for purposes of compliance with UDI labeling and data submission requirements only.